Du coeur artificiel au pansement en passant par les prothèses, lentilles correctrices, fauteuils roulants ou appareils de radiologie, la notion de dispositif médical recouvre un vaste ensemble de produits ayant en commun leur finalité médicale et leur action qui n’est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme. Les dispositifs médicaux ont été règlementés dans les années 1990 par des directives fondées sur les principes de la nouvelle approche (définition d’exigences essentielles et renvoi à l’harmonisation technique, place importante laissée aux acteurs professionnels et rôle limité conféré aux autorités publiques, évaluation de la conformité des produits par des organismes notifiés et absence d’autorisation de mise sur le marché). Malgré les avantages liés à leur souplesse, ces directives n’ont qu’imparfaitement réussi à garantir la sécurité des dispositifs médicaux, ainsi que cela a été rappelé dans le contexte de l’affaire des prothèses PIP : évaluation clinique, information et traçabilité des produits insuffisantes, contrôle par et sur les organismes notifiés limité, faible coordination entre les autorités, etc. Pour renforcer la sécurité des dispositifs médicaux européens, plutôt qu’une transposition du cadre juridique des médicaments ou des dispositifs médicaux américains, un cadre juridique sur mesure, adapté à leur niveau variable de risque, est à envisager. C’est ce que proposent les règlements qui seront prochainement adoptés. / From artificial heart to bandage through implants, corrective lenses, wheelchairs or radiology devices, the concept of medical device covers a wide range of products having in common their medical purpose and their action which is not obtained by pharmacological, immunological or metabolic means. Medical devices were regulated in the 1990s by directives based on the principles of the new approach (definition of essential requirements and reference to technical harmonization, important role for professional actors and limited role for public authorities, evaluation of the conformity of products by notified bodies and absence of marketing authorization). Despite the advantages of their flexibility, these directives have only partially succeeded in guaranteeing the safety of medical devices, as underlined in the circumstances of PIP implants scandal: limited clinical evaluation, information and traceability of products, limited control by and on notified bodies, lack of coordination between authorities, etc. To strengthen the safety of European medical devices, rather than transposing the legal framework of medicinal products or American medical devices, a custom-made legal framework, adapted to their varying level of risk, is to be considered. This is what the upcoming regulations put forward.

The diploma thesis deals with reporting of building in accordance with International Financial Reporting Standards and after that in accordance with Czech accounting regulations. The part, which is dedicated to IFRS, is focused to the reporting of company buildings according to the standards: IAS 16, IAS 40, IFRS 5 and IAS 36. The content of the next part is dedicated to Czech accounting regulations of company buildings especially to the Czech accounting standard no. 013. There is the comparison of the reporting of company buildings in accordance with IFRS and Czech accounting regulations as well. The last part of the diploma thesis is focused to the analysis of the selected financial statements.

Estudo de cunho comparativo-descritivo e analítico dos sistemas de saúde mental de Brasil e de Argentina através da consideração de alguns dos desdobramentos e construções da instalação do paradigma antimanicomial nos países em questão, colocando-os em conversação com as normativas emanadas das organizações internacionais, que vêm apoiando a mencionada mudança de paradigma desde 1975 até a atualidade. Nesse sentido, o principal referente será a Declaração de Caracas de 14 de novembro de 1990, produzida na Conferencia Regional para a Reestruturação da Assistência Psiquiátrica na America Latina assinada por ambos os países, que assumem assim o compromisso de reestruturação dos seus sistemas de saúde mental de acordo as recomendações emitidas. A análise se realiza através de três momentos: o estudo das legislações emitidas, o estudo das praticas existentes no campo e um estudo de caso sobre duas experiências pioneiras de instalação da lógica antimanicomial que foram efetuadas simultaneamente, uma em cada país. Toma como referência teórica os pressupostos do Movimento Institucionalista e os trabalhos de Michel Foucault, além do extenso ideário que sustentou a construção do paradigma antimanicomial: Basaglia, Tosquelles, Oury, Castel, e outros / A comparative, descriptive and analytical study of mental health systems in Brazil and Argentina, considering some of the developments and structures of implementation of the anti-asylum trend in the countries analysed and studying these factors in conjunction with regulations issued by international organisations in favour of this change in trend, from 1975 until the present-time. In this regard, the principal reference used in this study is the Caracas Declaration of 14 November 1990, created at the Regional Conference for the Restructuring of Psychiatric Care in Latin America, and signed by both countries, each therein committing to the restructuring of their respective mental health systems in accordance with the recommendations stipulated in the document. The analysis has three strands: a study of the published legislation, a study of existing practice in the Field, and a case study of two pioneering experiments of implementation of anti-asylum logic carried out simultaneously in each of the two countries. The study uses as theoretical reference the hypotheses of the Institutionalization Movement and the work of Michel Foucault, as well as the extensive ideology supporting the development of the anti-asylum trend: Basaglia, Tosquelles, Oury, Castel, and others

Esta tese tem como principal objetivo medir o desempenho das lâmpadas fluorescentes compactas em regime de uso intermitente instaladas em residências. Utiliza a Norma NBR 14539 e a PORTARIA 489/2010 como referência, para a comparação dos valores obtidos nas medições de campo com as medições do laboratório. A metodologia aplicada tem a finalidade de medir o desempenho em um ambiente real e muito mais agressivo que o laboratório. Foram instaladas 95lâmpadas de três marcas diferentes e dividida em três grupos, previamente as lâmpadas foram sazonadas ou \"envelhecidas\" por 100 horas e posteriormente instaladas nas residências. Neste estágio, as medições de campo foram realizadas durante dezoito meses em quatro oportunidades, (a primeira como referência), posteriormente foram retiradas e levadas novamente ao laboratório para medir a depreciação do fluxo luminoso. As variáveis medidas foram: Fluxo luminoso, iluminância, tensão, temperatura, umidade relativa e quantidade de chaveamento para o acendimento das lâmpadas. Para ter uma visão mais ampla, os resultados, foram comparados à norma brasileira com as normas internacionais em relação aos requisitos de desempenho das lâmpadas fluorescentes compactas. Também foi feito um questionário com os consumidores que participaram desta pesquisa, para verificar o conhecimento ou a \"cultura energética\" relacionada com a forma de uso da iluminação, manutenção dos circuitos, idade, gênero, situação laboral, classe social, consumo, escolha de lâmpadas na hora da compra, uso da iluminação natural, utilização de tintas claras no interior das residências. Todo procedimento de medições foi realizado no Laboratório de Fotometria do Instituto de Energia e Ambiente-IEE da Universidade de São Paulo/USP. / This thesis aims to verify the performance of compact fluorescent lamps (CFLs) that are installed in residences in intermittent use regime. It uses NBR 14539 and Ordinance 489/2010 as a reference for comparing the values measured in the field in the laboratory measurements. The methodology used to verify the performance in a real environment is more aggressive than the laboratory\'s. 95 lamps of three different brands were installed, which were divided into three groups, The lamps were previously seasoned or \"aged\" for 100 hours and then installed in residences. At this stage, the field measurements were conducted for eighteen months, four times until reaching 2,000 hours of use. Later, they were removed and taken back to the laboratory to check the depreciation. Measured variables were: Iluminância, voltage, temperature, relative humidity and the amount of switching to lighting the lamps. To consolidate, Brazilian standards were compared to international standards in order to verify if there are differences or coinciding points. A questionnaire was also filled in by consumers who participated in this research to verify the knowledge or \"energy culture\" related to the proper use of lighting, maintenance of circuits, age, gender, employment status, social class, consumption, choice of lamps at the time of purchase, use of natural lighting, use of clear paint inside the residences. Finally, it is worth mentioning that the entire measurement procedure was performed in the photometry laboratory of the Institute of Energy and Environment-IEE, University of São Paulo/USP.

Ce travail de thèse interroge l’application différenciée des politiques publiques et ses dynamiques.À travers l’étude de huit services publics d’assainissement non collectif, situés dans des espaces périurbains provençaux, hauts-alpins, vauclusiens et rhônalpins, la réflexion met en valeur les tensions entre des normes réglementaires et techniques d’une part et, d’autre part, des territoires disposant de ressources variables pour les appliquer. S’appuyant sur une démarche quantitative et qualitative auprès d’institutions et d’usagers, cette recherche met en évidence la grande différenciation des Spanc. Celle-ci s’explique par la difficulté, pour les Spanc, de s’imposer dans un jeu d’acteurs complexe et face à des usagers souvent récalcitrants. Notre recherche montre, au final, que la professionnalisation des agents de ces services, qui suppose le développement d’une identité, d’une culture et de pratiques communes, permet de réduire les différences d’application de la politique publique. / This research addresses the variations and dynamics of public policy implementation. Through the analysis of eight local authorities and their monitoring of individual waste water treatments, located in suburban and rural areas in southern France (Bouches-du-Rhône, Hautes-Alpes, Vaucluse, Rhône-Alpes and Var), our work highlights the conflict between regulations and technical standardson the one hand, and the unequal resources available for local authorities responsible for their implementation on the other. Adopting a qualitative and quantitative approach to institutions, employees and users, this research highlights the significant differences between local authorities in the service they provide for individual waste water treatments. These differences result from the difficulties experienced by local authorities in interacting with a complex network stakeholders and in dealing with often unwilling users. Our research shows that, the professionalisation process, which is built upon the development of a common identity, culture and practices, reduces differences in the implementation of public policy.

Snapping turtles (Chelydra serpentina) are being harvested in unprecedented numbers in the United States (US) to meet the needs of international markets. Over three million live snapping turtles from farm and wild caught stock were exported from the US to Asia in 2012-14 alone. In the Commonwealth of Virginia, records indicate that 29,860 snapping turtles were commercially harvested between 2000 and 2015. Size limits are often used to regulate harvest pressure in snapping turtles and other game species. I analyzed the historic harvest of eleven US states to test the efficacy of minimum-size limit regulations at reducing commercial harvest pressure. Further, I conducted a four-year mark-recapture study on three Virginia waterways that have each experienced a different level of historic commercial harvest. As part of the larger mark/recapture project, I conducted radio telemetry on 23 turtles to examine seasonal, body size, and sex-specific effects on home range size of snapping turtles in a lotic system. I incorporated survival and growth rates from this study, demographic rates from the literature, and state-collected harvest rates into a hybrid age/stage population matrix model to estimate the population growth rate at three harvest levels (0%, 21%, 58%) that were estimated based on annual commercial landing reports on file with the Virginia Department of Game and Inland Fisheries. I used the model to test population viability under multiple size limit regulations, and used sensitivity analyses to identify adult stages most critical to the overall population growth rate. Based on model estimates, size-limits were effective at reducing harvest by 30-87% in years with high harvest pressure. However, most size limit regulations result in the removal of larger breeding adults, which has been shown to be detrimental to long term population viability. Based on radio-telemetry data, I found evidence that snapping turtles utilize lotic and lentic habitats differently, which can have implications for management of this iconic species. Matrix population modelling predicted that population densities at the moderate and high harvest site were reduced by 47% and 62%, respectively, when compared to the no harvest site. Model results indicate that, while an increase to the minimum-size limit in 2012 protected a larger portion of the population, that the commercial harvest of snapping turtles in the Commonwealth of Virginia is not sustainable under current state regulations. Our analysis suggests that minimum-size limits of 35.6 cm curved carapace length or greater will maintain viable populations by protecting a larger portion of reproducing snapping turtles within a population.

The objective of this study was to determine the patterns of regulatory noncompliance, as identified by the U.S. Food and Drug Administration (FDA), and their effects on meta-analyses. In order to achieve these objective, three studies were undertaken: analysis of citations issued by FDA Investigators at the conclusion of an inspection; analysis of regulatory actions taken by the FDA towards clinical researchers based on the observations cited by FDA Investigators; and sensitivity analysis of meta-analyses based on the Agency’s determination of research misconduct, primarily the falsification of data. FDA Investigator citations were analyzed using Chi-Square analysis based on geographic location of the inspection, type of inspection, and type of violation. Temporal changes in the number of inspections and the violations cited were analyzed using bivariate Poisson regression models. Bonferroni correction was employed for temporal changes across the time period analyzed. Regulatory actions taken by the agency were analyzed via Chi-Square or Fisher’s exact test based on changes identified in previous publications, temporal changes, and differences between regulatory action types. Sensitivity analysis of meta-analyses identified through a systematic review were assessed both qualitatively and quantitatively for the effects of including publications of apixaban trials with significant FDA regulatory action, i.e. the comparison of odds ratio point estimate, upper and lower 95% confidence interval, both before and after consideration of falsified data. Under the FDA’s Bioresearch Monitoring program from 2007-2015, the number of inspections increased, but the rate of citation issuance per inspection decreased. One third of the violations were related to adherence to investigational procedures followed by informed consent violations and violations involving study records. During this same time period, 194 clinical researchers received a regulatory action based on FDA’s review of inspection results. Since 2007, rates of significant deviations had decreased. Lack of researcher supervision and submission of false information were cited more frequently for disqualification proceedings. A systematic review found 99 statistical analyses from 22 different meta-analyses available for sensitivity analyses. Nearly one-third resulted in a change in the conclusions reported in the originally published statistical analyses. In approximately the last decade, the number of violations cited during inspections under the Bioresearch Monitoring program has decreased; however, significant improvements can continue to be made regarding adherence to study procedures, the consenting of human subjects, and creation of adequate and accurate study documentation. Disqualification of clinical researchers is more likely to occur when researchers fail to supervise a clinical trial or false information is submitted to the FDA. Falsified data can make its way into the exploding field of meta-analyses, a study method that provides a concise and compelling method for the dissemination of medical intervention knowledge; however, this method can be highly unstable and can provide biased results. A robust sensitivity analysis that considers data quality from available sources can help ensure calculations of the best estimates.

This thesis reports on the modification of the "Safecode" computer-program to monitor the safety of radio-isotope laboratories, and its application to 24 compliance audits in NSW during the period 1999 to 2006. Additionally, an attempt was made to predict the level of risk to persons working within those laboratories. Based on the current NSW radiation control legislation and the relevant Australian Standards a comprehensive audit checklist was developed for this project. Each safety requirement in those documents was used to develop a question, resulting in 187 questions in the checklist. The questions were grouped into the following seven Topic Elements: Licensing and Registration; Radiation Safety Administration; Personal and Area Monitoring; Dose Limit Compliance; Documentation/Records; RSO/RSC Qualifications and Duties; and Facilities. A novel feature was the allocation of "weighting factors" to individual questions and Elements. The computer program facilitated analysis of data and provided output in spreadsheet and graphical form. .The on-site physical audits were conducted using the project check-list, and were supplemented by discussions with the client's representative. The results showed significant variation between sites with overall compliance scores ranging from 37% to 94%. The reasons for this large variation stem from differences in local management regime; the appointment of an RSO at one site; variation in the extent of adoption of relevant codes of practice; and legislative weaknesses. Further analysis of the data presented legal, advisory and combined scores for each Element for each site; and variations over time. The graphic displays of the results were appreciated by client management. The formula developed to predict risk, based on the physical parameters alone, showed little relationship to the total audit scores. Statistical analysis of the two data groups by correlation coefficient confirmed this general finding. Development of the formula however served to indicate deficiencies in the Question Set, and the importance of human factors in achieving a high degree of safety.

本研究係探析保險業在監理管制下，若有違監理標準之虞時，其經理人是否興起盈餘管理的動機，以避免不必要的監理成本。蓋保險監理最重要的目的為預防保險公司失卻清償能力，以保障被保險人的權益，並維持金融安定。在實施風險基礎資本制前，邊際清償能力的標準仍以保險法第143條第一項之規定為依歸，即保險業認許資產減除負債之餘額，未達實收資本之45%時，主管機關應命其於限期內，以現金增資補足之。若保險業不依第143條規定限期增資補足者，保險法第149條第二項授權主管機關應依情節輕重，分別處以派員監理、撤換負責人或有關人員、限期改組、甚至命其停業或解散。故本研究預期清償能力不佳的保險公司，其經理人會動用裁量性應計項目調整財務狀況，以跨過清償能力標竿，避免受到監理機關的注意與查核。另外，保險法對於保險業資金運用管道有所縮限，以驅使保險公司穩健地運用資金，預防保險公司因巨額投資損失致使清償能力敗壞。但隨著產業競爭度增強與低利率時代的來臨，保險公司在經營績效與保單預定利率的壓力下，是否會安於目前的投資限制，而放棄賺取投資報酬的機會。據此，本研究預期年度中持有短期有價證券總額超過或可能超過35%資金門檻的保險公司，其經理人會選擇處分位於利得部位的短期有價證券，以規避超過保險法第146條之1第一項第二款的門檻限制。同理，年度中持有合格的公司股票及公司債超過或可能超過35%資金門檻的保險公司，其經理人可能會選擇出售位於利得部位的股票或公司債，以規避超過146條之1第一項第三款的門檻限制。 　　在研究設計上，為捕捉各類操縱財務報表的淨影響，本研究採用總裁量性應計項目作為代理變數。在所有可用的裁量性應計項目估計模型中，研究指出Modified Jones模型顯示了相對較強的檢定力(Dechow et al. 1995)。因此本研究援引Modified Jones模型估計裁量性應計數字。其次，將該模型析出的裁量性應計數字與各類監理門檻距離組成一迴歸模型，以測試其關聯性強弱。實證結果如下：一、在產險業，保單持有人盈餘與實收資本之45%的距離愈小者，其盈餘管理幅度愈大。二、壽險業比較沒有利用裁量性應計項目來達到監理標準的動機。但依公司規模來看，大小公司行為仍有所差異，即相較於大公司，小公司利用裁量性應計項目來達到監理標準的動機較為強烈。根據本文實證研究結論，建議監理機關與被保險人應特別注意產險業及小壽險公司的財務狀況，並確認其清償能力之品質。 / This paper examined whether insurance companies have incentives to manipulate accounting accruals to appear more solvent and less risky. In Taiwan, virtually all industries are regulated to some degree, but insurance industry faces regulatory monitoring that is explicitly tied to accounting data. Insurance regulators required that insurers meet conditions for minimum financial health. It is frequency asserted that such regulations create incentives to manipulate financial statement to avoid regulatory intervention The primary hypothesis of this paper is that the incentive to manipulate financial statement is a decreasing function of the insurers’ difference between policyholders’ surplus and 45% of capital. This paper assumes that insurance managers use their reporting discretion to achieve solvency goal and avoid exceeding investment limits. Following Healy (1985), accruals-based measures are wide employed in test of earnings management hypothesis. In the past, the most frequency used techniques for estimating discretionary accruals are the cross-sectional versions of the modified Jones model. In this paper, the magnitude of earnings management is proxied by the discretionary accruals which are estimated by using a cross-sectional version of the modified Jones model and regressed by three differences of regulatory requirements which measure the insurers’ behavior under the regulation. The evidence indicates that when policyholders’ surplus of property-casualty insurers is closer to 45% of capital, the incentive to manipulate financial statement is stronger. On the other hand, life insurers have less incentive to manipulate financial statement, but relative to big size insurers, small size insurers have stronger incentive to meet regulatory requirements.

Thesis (M.Pharm. (Pharmacy Practice))---North-West University, Potchefstroom Campus, 2008.